Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side. Participation involves the surgical implantation of an electrode (small electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which will enable treatment for migraine headaches. Tiny electrical current is delivered to the stimulator device by an internal pulse generator implanted in the area at the top of the chest, to stop the migraine headaches. The implant system will be controlled with a wireless remote provided after the implant procedure.
Participation will record headache diaries throughout the study, which will last approximately 8½ months, and a yearly visit annually for five years.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches|
- Migraine Relief at 2 Hours Post Stimulation [ Time Frame: 8.5 Months ]Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
- Migraine Free at 2 Hours [ Time Frame: 8.5 Months ]Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.
- Pain Free at 2 Hours Post Stimulation [ Time Frame: 8.5 months ]As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
- Acute Migraine Medication Use [ Time Frame: 8.5 months ]During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.
- Headache Impact Test (HIT-6) Compared With Baseline [ Time Frame: 8.5 months ]The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.
- Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline [ Time Frame: 8.5 months ]The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.
- Stimulation Related Adverse Events [ Time Frame: 8.5 months ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Average Per Subject Reduction in Migraine Days/Month [ Time Frame: 8.5 months ]During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.
- Implantation and Stimulation Related Adverse Events [ Time Frame: 8.5 months ]As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
- Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia [ Time Frame: 8.5 months ]Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.
|Study Start Date:||March 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Deep brain stimulation of SPG for migraine
Electrical SPG for Treatment of Migraine
Device: Deep Brain Stimulation of SPG for Migraine
Deep Brain Stimulation of SPG for Migraine
Other Name: Medtronic 37702 PrimeAdvanced™
This application proposes a clinical study of electrical stimulation of the sphenopalatine ganglia (SPG) as a treatment for up to three individuals with episodic migraine headache. The present study is aimed at obtaining pilot data to guide a future controlled trial of this treatment modality. The study population will include individuals suffering from episodic migraine headaches with chronic severe disability, as demonstrated by the Migraine Disability Assessment Questionnaire (Lipton, 2000) and Headache Impact Test short form (HIT-6™) (Kosinski, 2003).
The treatment involves implantation of an electrode into the SPG. The electrode is connected subcutaneously to an infraclavicular stimulator (PrimeAdvanced™ 37702 Multi-program Neurostimulator System, Medtronic Inc., Minneapolis MN). Proper electrode placement will be verified using anatomic and physiologic techniques. Participants will receive the Medtronic Model 3389 or 3387 lead, or Medtronic subcompact lead Model 3776-45, 3776-60, or 3776-75. Stimulation will be delivered in a range of frequencies from 20 to 130 Hz, and pulse width from 60 to 450 μsec, and a titrated voltage. The voltages used for chronic stimulation may range up to the pulse generator maximum of 10.5 volts but are anticipated to generally be below 3 volts, keeping below the 30 µcoulomb/cm² charge density safety limit, and below the threshold for adverse stimulation-related effects. The minimum number of contacts on the quadripolar leads will be activated as necessary to produce a response.
The Prime Advanced neurostimulator to be used in this study allows the clinician to set all stimulation parameters including the maximum allowable amplitude. It is our responsibility to assure that appropriate stimulation parameters are used to result in appropriate electrical exposure charge density) below a 30 µC/cm2/phase limit. As is done with commercially available neurostimulators, during this study, we will utilize the charts presented in Figures 1 and 2 below to assist in selection of programming parameters, and this programming will be maintained by software controls within the neurostimulator.
For this exploratory study of 3 patients, the maximum electrical stimulating parameters, resulting electrical exposure (e.g., charge density), will be determined using the methods described above. It is our responsibility to assure that safe stimulation parameters are used at all times and that the maximum settings do not exceed the safety limits. Our plan is to begin with lead 3776 if possible, because it does not require an extra extension, but we would use 3387 or 3389 if clinically indicated.
The proposed study is a physician-sponsored research investigation of three patients, and the attention to stimulation parameters will be much greater than can be expected for a commercially released product. It is our responsibility within this investigational study to insure the selected stimulation parameters do not exceed the safety limit of 30μC/cm2/phase. Patients participating in the study will only be able to lower stimulation amplitudes, thereby keeping stimulation parameters BELOW any clinician set maximum. The only programs available to or accessible by the patients will maintain the previously described parameter set limitations. Thus, the programming of the Implantable Programmable Generator (IPG) will keep the three patients from stimulating outside or above the set and safe parameters.
The primary outcome measures for assessing the efficacy of migraine treatment will be a subject reported daily diary noting frequency and intensity of headaches. During this investigation we will obtain preliminary controlled data on the safety and efficacy of SPG stimulation for migraine treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294046
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Stewart J Tepper, MD||The Cleveland Clinic|